BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 18187968 · Received November 21, 2023

    Report

    Report Number
    3014590708-2023-00033
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 29, 2023
    Report Date
    December 5, 2023
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPERATIVE CARE, INC. RECEIVED THE PROXIMAL SEGMENT OF THE ZOOM 71 FOR INVESTIGATION. INVESTIGATION CONFIRMED SHAFT BREAKAGE AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED TO THE ZOOM 71 DURING THE PROCEDURE RESULTING IN STRETCHING OF THE SHAFT MATERIALS PRIOR TO THE DEVICE BREAKING. INVESTIGATION DEMONSTRATED STRETCHING AND KINKING OF THE PROXIMAL SEGMENT OF THE ZOOM 71. IT WAS OBSERVED TO HAVE A SECTION OF STRETCHED OUTER JACKET WITH THE COILS PULLED OUT. BASED ON THE COMPLAINT INFORMATION PROVIDED AND DEVICE INVESTIGATION THE EXACT ROOT CAUSE FOR THE ZOOM 71 SHAFT BREAK COULD NOT BE DETERMINED. FACTORS THAT WERE IDENTIFIED TO CONTRIBUTE TO THE DEVICE COMPLAINT ARE THE REPORTED VERY TIGHT ANTERIOR GENU OF THE INTERNAL CAROTID ARTERY (ICA) AND RETRACTION OF THE ZOOM 71 AGAINST RESISTANCE.

    Additional Manufacturer Narrative · 0

    IMPERATIVE CARE INC. HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION. AS THE DEVICE HAS NOT BEEN RETURNED, THE EXACT ROOT CAUSE OF THE SEPARATION COULD NOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, WHEN THE DEVICE IS RETURNED, AND INVESTIGATION IS COMPLETED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY.

    Description of Event or Problem · 0

    REFER TO H10 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    A PATIENT PRESENTED WITH AN OCCLUSION AT THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. ACCESS WAS OBTAINED THROUGH THE RIGHT RADIAL ARTERY USING A GUIDEWIRE AND A ZOOM RDL. THE PATIENT'S ANTERIOR GENU OF THE INTERNAL CAROTID ARTERY (ICA) WAS REPORTED TO BE VERY TIGHT. THE ZOOM RDL WAS PLACED AT THE ANTERIOR GENU. FOR PASSES ONE AND TWO, THE ZOOM 71 WAS ADVANCED THROUGH THE ZOOM RDL TO THE CLOT LOCATION. THE ZOOM RDL RETRACTED BACK TO THE POSTERIOR GENU WHEN THE PHYSICIAN WAS ADVANCING THE ZOOM 71 TO THE CLOT. THE SAME ZOOM 71 AND ZOOM RDL WERE USED DURING THE FIRST TWO PASSES. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE ZOOM 71 AFTER THE SECOND PASS, THE ZOOM 71 WAS POSITIONED IN THE DISTAL ICA BEFORE THE ICA TERMINUS. RESISTANCE WAS FELT DURING RETRACTION OF THE ZOOM 71 AND THE ZOOM 71 FRACTURED AT THE DISTAL PORTION OF THE CATHETER WITH THE MARKER BAND STILL ATTACHED TO THE BROKEN DISTAL END. THE EXACT LENGTH OF THE BREAK WAS NOT PROVIDED. AFTER THE FRACTURE, THE TIP OF THE ZOOM 71 WAS NOTED TO BE IN THE COMMUNICATING SEGMENT OF THE ICA. NO KINKS WERE OBSERVED ON THE ZOOM RDL. A V18 GUIDEWIRE WAS USED TO PULL THE FRACTURED ZOOM 71 SEGMENT INTO THE ZOOM RDL. UNDER ASPIRATION, THE ENTIRE FRACTURED SEGMENT OF THE ZOOM 71 AND THE ZOOM RDL WERE REMOVED COMPLETELY FROM THE PATIENT AS A SYSTEM. FOR PASSES THREE THROUGH SIX, THE PHYSICIAN USED A NEW ZOOM RDL, A NEW ZOOM 71, A THIRD PARTY MICROCATHETER, AND A STENT RETRIEVER TO COMPLETE THE CASE. A TICI 2B SCORE WAS ACHIEVED, AND THE PATIENT WAS REPORTED IN STABLE CONDITION. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744120 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2313901 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SL-10 MICROCATHETER.| STENT RETRIEVERS.| V18 GUIDEWIRE.| ZOOM RDL.